前段时间,美国食品和药物管理局(FDA)批准抗癌药Acalabrutinib,用于慢性淋巴细胞白血病(CLL)或小细胞淋巴瘤(SLL)成人患者治疗。此前,Acalabrutinib获美国FDA加速批准,用于既往已接受至少一种疗法的复发性或难治性套细胞淋巴瘤(MCL)成人患者。 Acalabrutinib试验数据 新药Acalabrutinib的此次批准,主要是基于2项III期临床...
美国食品和药物管理局(FDA)于2019年批准阿卡替尼(Acalabrutinib)用于治疗未经治疗的成人复发性/难治性慢性淋巴细胞白血病(CLL)或小淋巴细胞淋巴瘤(SLL)。 Byrd博士和他的同事展示了首次二期试验的成熟结果,以评估阿卡替尼(Acalabrutinib)在未经治疗的CLL患者中的应用。 在ACE-CLL-001试验的扩张阶段,总共99名患者(...
The FDA has approved acalabrutinib (Calquence) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).1,2 The approval, which was done under the FDA’s Project Orbis initiative, was based on 2 phase III randomized trials—ELEVATE-TN and...
今天,美国FDA宣布,批准阿斯利康(AstraZeneca)公司(http://www.maoyihang.com/company/)的BTK抑制剂Calquence(acalabrutinib),作为初始疗法或后续疗法,治疗慢性淋巴性白血病(CLL)或小细胞淋巴瘤(SLL)成人患者。 Calquence是阿斯利康开发的BTK抑制剂,它可以与BTK共价结合,抑制其活性。 临床前试验表明,与“first-in-class...
Acalabrutinib FDA approval was granted on October 31, 2017, for treating MCL. Its approval was later expanded to include CLL and SLL. Acalabrutinib (brand name Calquence) is manufactured by AstraZeneca Pharmaceuticals.How does acalabrutinib work?
Acalabrutinib was approved by the FDA in November 2019 for the treatment of adult patients with CLL or SLL based on data from the phase 3 ELEVATE-TN (NCT02475681) and ASCEND trials. A year later, in November 2020, the BTK inhibitor also gained approval by the European Union for patients...
2015年9月被美国FDA授予治疗MCL的罕用药地位;2016年3月被欧盟授予治疗复发性与难治性慢性淋巴细胞白血病(chronic lymphocytic leukemia,CLL)、MCL和华氏巨球蛋白血症 (Waldenstrom macroglatulinemia,WM)等3种疾病的罕用药地位。2017年8月,FDA授予阿卡替尼治疗MCL的突破性药物资格,2017年10月31日根据Ⅱ期临床试验治疗...
Acalabrutinib:Brand name, FDA approval, Indications and Side effects Acalabrutinib is an oral inhibitor of Bruton's tyrosine kinase that is used in the therapy of B cell malignancies including re... Mar 24,2025 Acalabrutinib: Uses, Interactions, Mechanism of Action Acala...
On January 27, 2023, Eli Lilly announced that the FDA has granted accelerated approval for its next-generation Bruton's tyrosine kinase (BTK) inhibitor, Pirtobrutinib, to traet relapsed or refractory mantle cell lymphoma (MCL) in adult patients who have received at least two prior therapies, ...
近日,美国食品和药物管理局(FDA)批准新型抗癌药Calquence(acalabrutinib)口服胶囊为突破性药物资格(BTD),作为一种单药疗法治疗慢性淋巴细胞白血病(CLL)成人患者。CLL是成人最常见的白血病类型之一。 Calquence于2017年10月获美国FDA加速批准,用于既往已接受至少一种疗法的复发性或难治性套细胞淋巴瘤(MCL)成人患者。目前...